MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A34-34/C100-O20 V

Device Problems Material Puncture/Hole (1504); Stretched (1601); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following observation: type iiib endoleak (with stent cage dilation) of the cuff (124%).This complaint is most likely user-related due to 25mm main body with a 34mm cuff (and multiple cuffs).The manufacturing lot review confirmed all devices met specifications prior to release.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events: upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.

Event Description

During the clinical assessment of a previous reported event (2031527-2018-00931), clinical was able to find substantial evidence to support the following additional findings of a type iiib endoleak and stent cage dilation of the cuff (vela suprarenal).This report is only for the cuff.Please refer to the previously reported event, if needed for additional information.

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 8284782
• MDR Text Key: 134327758
• Report Number: 2031527-2019-00060
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)181007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2018
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1252492-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED STENT GRAFT: 1251751-058; AFX-VELA INFRARENAL: 1252183-026; AFX-VELA INFRARENAL: 1252183-027
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR